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Constitutionality Of SDB Preference Still Undecided

Client Alert | less than 1 min read | 07.12.05

Expressing some frustration, the Federal Circuit in Rothe Dev. Corp. v. Dep't of Def. (June 28, 2005) remanded to the district court a second time for a determination of whether the latest enactment of the small disadvantaged business evaluation preference is constitutional, despite the price percentage bonus currently being suspended. The Federal Circuit repeated that the district court must apply strict scrutiny and must review evidence as to what Congress considered in establishing the preference.

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Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....